Questions and Answers
The Department of Pharmacy at the Ministry of Health is the body responsible for prescribing drugs, importing drugs, pharmacist control, providing pharmacological information, approval and supervision of human clinical trials, research on the effects of drugs on humans, herbal medicine approval, homeopathic products and cosmetics. Medicines used in Israel must be registered in the Medicines Register. A drug will only be prescribed after its safety, efficacy and quality have been demonstrated.
Due to the health danger of taking counterfeit medicines, be aware of the following warning signs:
- The drug is not listed in the Ministry of Health-approved drug repository
- The drug or product packaging lacks Hebrew and English consumer leaflets
- Essential details are missing from the packaging, such as manufacturer name, validity, batch number
- Product packaging has spelling errors
- Tamper evidence mechanism does not exist or is torn
- The drug/preparation was not purchased at a licensed pharmacy but via the internet, in a neighborhood grocery store or from an unauthorized person
- There are suspicious signs on the product packaging, such as foreign language captions in Chinese, Thai, Indian or other languages
Registration of medicines is carried out in the register of medicinal products in the Department of Pharmacy of the Ministry of Health. According to the Pharmacy Regulations, a drug will only be registered in the Register of Medicines after its safety, efficacy and quality have been proven.
An active ingredient is a chemical that is usually a small molecule produced in chemical synthesis processes, while a biological drug is based on components and processes derived from animal or fermentation and/or tumor microorganisms/cells.
1. Molecular weight: Biological drugs, such as peptides and proteins, are huge molecules compared to chemical drug molecule sizes.
2. 3D Structure: Proteins, unlike chemical drugs, have a 3D structure that affects their function.
3. Manufacturing process: The production process of a chemical drug is synthesized for specific molecules in a known process. The biological drug production process, on the other hand, is much more complex and may result in high variability of the final product.
The drug development process is a lengthy process, and one of the longest, most expensive and significant stages is the clinical phase, whose purpose is to show that the drug is safe to use and effective. The first phase of clinical studies (Phase 1) is the first human study, and comes after laboratory and animal studies (preclinical). The second phase (Phase 2) is the phase in which the drug’s effectiveness in humans begins to be tested. Phase 3 is the last step before submitting the product for regulatory approval. Phase 3 is the most valuable and significant stage because testings is being done on a larger population and in multiple locations. Phase 4 (post-market) studies deal with collection of clinical data after marketing the drug, in order to complete and process information about the drug’s safety and efficacy.
In accordance with the Pharmacy Regulations (proper production conditions), each batch and shipment of medical product imported into Israel, prior to release and marketing in Israel, must obtain authorization from a responsible pharmacist or Qualified Person (QP). The role of QP pharmacist is to ensure the quality of the preparations and to ensure that they are manufactured in proper production conditions according to current good manufacturing practice (GMP), shipped and stored in accordance with proper and current good storage practice (GSP) and under conditions of current good distribution practice (GDP).
Pharmaceutical crime is defined as the complex of offenses related to drugs, raw materials to produce drugs, and cosmetics. The introduction of counterfeit pharmaceutical or cosmetic products into the distribution and marketing system endangers public health, and many efforts are being made to minimize such phenomena.
Counterfeit medicines are medicines and medicinal products supplied by manufacturers which are unregistered and unapproved by the Ministry of Health.
Good manufacturing conditions, or good maufacturing practice (GMP), in the pharma industry are designed to ensure that the pharmaceutical products are manufactured in accordance with the requirements of the factory quality system. Implementation of GMP will minimize risks associated with production processes. GMP covers all aspects of production, ranging from vendor or suppler certification, raw material acceptance and storage, cleanliness and production facility infrastructure and support systems, production equipment, employee conduct and training, and cleaning and validation processes.
In Israel, Ministry of Health audit and enforcement procedures are carried out to evaluate and enforce GMP requirements.
In the US, GMP requirements are described and enforced for drugs and medicines under 21 CFR parts 210 and 211, and for medical devices under 21 CRF 800.
In Europe, GMP requirements for drugs and medicinal products are described and enforced as part of Directive 2003/94/EC, and for medical devices under the Medical Device Directives and the 2017 Medical Device Regulations.
A risk management plan (RMP) is an important tool used to detect, characterize, assess and minimize risks associated with the use of a medical device.
A risk management program includes three main steps:
- Characterization of the medical device safety profile, which includes both known safety information and what is still unknown about the product.
- Planning pharmacovigilance activities designed to characterize known risks, identify new risks and expand knowledge of the product safety profile.
- Planning and implementing a risk mitigation plan, as well as assessing the effectiveness of these activities.
A pharmaceutical quality system is designed to ensure the safety and quality of the product and minimize risk to the consumer’s health. There are many ways in which regulatory requirements and the responsibility of the organization can most effectively be implemented, including the use of audit documents, training and certifications, validation investigations, corrective and preventative actions (CAPA), and more.
Validation is well-documented proof with a high level of confidence that a system, equipment, software, test method, drug manufacturing, sterilization or cleaning process will be consistently and robustly delivered, providing a result that meets the requirements of predefined specifications in approved validation protocols.
The purpose of the validation process is to ensure that a pharmaceutical product meets all quality, efficacy and safety requirements that have been set for the final product, during all stages of production and in different batches of the same product, while adhering to a controlled and documented process.
Validation processes includes a validation plan (VP), risk assessment, system design or design qualification (DQ), installation qualification (IQ), operational qualification (OQ), system performance qualification (PQ), production process qualification (PPQ), and validation of cleaning processes, software and control systems and repeat/periodic validation.
A sterile product is a product free of live microorganisms and will usually undergo terminal sterilization in its final packaging (heat sterilization, steam, gamma radiation, ethylene oxide, etc.).
An aseptic product is a product that cannot be terminally sterilized for various reasons, such as product stability, heat sensitivity or radiation sensitivity.
As a result, such a product should undergo preparation, filling, and sometimes packaging, under conditions that will maintain its sterility.
Rule 29c is part of the State of Israel Pharmacy Regulations (Preparations) 1986, and is a specific, individual permit to import a drug that is not registered in the State of Israel for the purpose of using it as part of medical treatment or, alternatively, for permission to use a registered drug in a previously unregistered form.
The Pharmacists Ordinance, 1981, defines “drugstore” as “a business conducted by a responsible pharmacist approved by the Director in this matter and used for the storage, wholesale sale or wholesale distribution of drugs or raw materials for the manufacture of drugs”.
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